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固体制剂中的药物,由于主药及赋形剂的化学和物理性质,容易引起各种分解反应。同时,由于它的不均一性,很多是复杂的分解,其分解机理大部分还未能了解。因此,予测固体制剂的稳定性是困难的。然而,用简易而灵敏的方法从各种因素中来测知对药物稳定性的影响,在药品的质量管理和制剂设计方面是十分必要的。作者等用漫反射光谱法(DRS)在药物加速试验中测定变色和分解,同时与其他定量法作比较,探讨DRS作为稳定性简易筛选试验法的适用性和其应用范围。实验部分色差法、DRS及吸收度法定量研究变色度:
The drugs in solid preparations easily cause various decomposition reactions due to the chemical and physical properties of the main drugs and excipients. At the same time, due to its heterogeneity, many are complicated decompositions, and most of the decomposition mechanisms have not yet been understood. Therefore, it is difficult to predict the stability of a solid preparation. However, using a simple and sensitive method to detect the influence on drug stability from various factors is very necessary for the quality control of pharmaceuticals and formulation design. The author uses diffuse reflectance spectroscopy (DRS) to measure discoloration and dissociation in drug accelerated tests and compares with other quantitative methods to explore the applicability of DRS as a simple screening test for stability and its application. Experimental part of the color difference method, DRS and absorbance method for quantitative study of color change degree: